Kornimate/medical-research-clean huggingface dataset:
safety of ovarian stimulation with letrozole and gonadotropins in breast cancer patients

Conditions: Breast Cancer

Summary: breast cancer patients are commonly treated with drugs that eggs present in the ovary and may reduce their chance for getting pregnant. their fertility can be preserved by stimulating their ovaries, collecting multiple eggs, fertilize them in the lab and freeze them. ovarian stimulation increase their estrogen levels in blood.this may stimulate their cancer and increase chance for recurrence. if a medicine that prevent estrogen rise is used (letrozole), this may increase the safety of stimulation. in this study we compared ovarian stimulation in breast cancer patients using letrozole with those who did not undergo stimulation and showed that there is no increase risk for recurrence after a median follow up of 2 years

215 women with breast cancer were evaluated for fertility preservation before chemotherapy. of those, 79 elected to undergo controlled ovarian stimulation (coh) with letrozole and gonadotropins for embryo or oocyte cryopreservation. the 136 patients who declined served as controls.there were no significant differences between the study and control groups regarding age at diagnosis, breast cancer prognostic parameters (tumor size, grade, number of positive lymph nodes, estrogen receptor status, her2-neu overexpression and vascular space invasion), and chemotherapy regimens. there was no difference between the two groups in the projected 10 year relapse, breast cancer specific mortality or overall mortality. there were 3 recurrences or contralateral breast cancers (2 distant, 1 locoregional) in the letrozole group, and 11 in the control group (9 distant, 1 locoregional, 1 contralateral breast). comparison; breast cancer patients that underwent ovarian stimulation with letrozole+gonadotropins and those who declined ovarian stimulation.

Eligibility criteria:
inclusion criteria: * age 18-45 years * biopsy proven breast cancer * no prior chemotherapy or oophorectomy * regular menstrual cycles * normal basal fsh and estradiol exclusion criteria: * stage 4 breast cancer

Keywords: breast cancer ovarian stimulation aromatase inhibitors letrozole fertility preservation recurrence
a phase 2 study of sym-1219 to treat bacterial vaginosis

Conditions: Bacterial Vaginosis

Summary: the purpose of this research study is to test the safety and effectiveness of the oral investigational new drug, sym-1219, for the treatment of bacterial vaginosis.

:this was a phase 2, multi-center, prospective, randomized, double-blind, placebo-controlled study to evaluate the effectivenessand safety of sym-1219 in women with bacterial vaginosis. patients determined to be eligible for the study were randomized to one of the following treatments: sym-1219 1 gram orallyas a single dose;sym-1219 2 grams orally as a single dose;or matching placebo. patients determined to be eligible based on the clinical assessments at the baseline visit (day 1) were randomized in a 1:1:1 ratio and received a singledose of the assigned study treatment on day 1 under fasted conditions (i.e., no food 2 hours prior to or 1 hour after dosing). the centralized randomization was stratified by the number of reported episodes of bv in the past 12 months (including the current episode): 3 or fewer episodes versus 4 or more episodes. patients were asked to complete a daily telephone questionnaire on days1to7 and at the test of cure (toc)/end of study (eos)visit. patients were also contacted by telephone once on day 8 to 10 to inquire about possible adverse events (aes). a toc visit was conducted between day 21 and 30; or at eosif the final visit was notconducted between day 21and30

Eligibility criteria:
inclusion criteria: * are females at least 18 years of age in good general health who are not menopausal. * have a clinical diagnosis of bacterial vaginosis, defined as having all of the following criteria: * off-white (milky or gray), thin, homogeneous vaginal discharge * vaginal ph ≥ 4.7 * presence of clue cells of ≥ 20% of the total epithelial cells on microscopic examination of the vaginal saline wet mount * a positive 10% koh whiff test. * have a gram stain slide nugent score ≥ 4 at the baseline visit (day 1) exclusion criteria: * are pregnant, lactating, or planning to become pregnant during the study. * are suspected clinically (or confirmed diagnostically) of having alternative causes of vaginal symptoms including candidiasis, chlamydia trachomatis, trichomonas vaginalis, neisseria gonorrhoeae or herpes simplex. * have received antifungal or antimicrobial therapy (systemic or intravaginal) within 14 days prior to the baseline visit (day 1).
hydralazine valproate for ovarian cancer

Conditions: Ovarian Cancer

Summary: the current standard for recurrent, persistent or metastatic cisplatin-resistant ovarian cancer is palliative chemotherapy with either topotecan, liposomal doxorubicin or gemcitabine, however, the results need to be improved. epigenetic aberrations play an important role in cancer progression by silencing growth regulatory genes and there is now evidence that inhibitors of dna methylation and hdac inhibition synergize the cytotoxicity of chemotherapy. objective. to determine the superiority of epigenetic therapy with hydralazine and valproate plus topotecan over placebo plus topotecan upon progression-free survival. hypothesis. hydralazine and magnesium valproate associated to topotecan will increase progression-free survival from 6 to 9 months as compared with the same regimen of chemotherapy plus placebo.

randomized, double-blind phase iii trial. a total of 211 patients (alpha 0.5, power 0.8)with cisplatin-resistant recurrent or persistent cancer will be randomized to topotecan + placebo or topotecan + hydralazine + valproate for 6 courses every 4 weeks. patients will receive an oral dose of hydralazine of 182mg (rapid) or 83mg (slow) according to the acetylator phenotype in a single daily dose and magnesium valproate at an oral dose of 40mg/kg t.i.d. both drugs in a slow-release formulation. experimental drugs or placebo will start from seven days before day 1 of chemotherapy until the end of the sixth course.

Eligibility criteria:
inclusion criteria: * measurable or evaluable disease(evaluable according to ca125 criteria of gcig) cisplatin resistant ovarian cancer * persistent or progression to first line platinum-based chemotherapy * relapse within 6 months after completing first line platinum-based chemotherapy * platinum-sensitive disease who are failed to second line therapy based on platinum. * adequate organic function as defined by: hemoglobin \>10 g/l, leukocytes \>4000/mm3, platelets \>100 000mm3; normal creatinine value and creatinine clearance \>60 ml/min; total bilirubin \< 1.5 upper normal limit value exclusion criteria: * history of allergy to hydralazine or valproate; * past or present condition of rheumatic disease, central nervous system disease, heart failure from aortic stenosis and postural hypotension as diagnosed by a physician; * newly diagnosed hypertension patients with or without pharmacological treatment are allowed as long as their treatment do not include hydralazine. * previous use of the experimental drugs (hydralazine and magnesium valproate) as well as if patients were pregnant or breast-feeding. other exclusion criteria are uncontrolled systemic disease or infection.

Keywords: epigenetics, hydralazine, valproate, ovarian cancer
study to assess if abp 798 is safe & effective in treating moderate to severe rheumatoid arthritis (ra) compared to rituximab

Conditions: Arthritis, Rheumatoid

Summary: this trial is designed to determine what effects the human body has on the investigational medicine, abp 798, and what effects the body has on the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, rituximab, in patients with moderate or severe ra. this study will also assess if the investigational medicine is safe and effective in treating moderate or severe ra compared to the licensed medicine.


Eligibility criteria:
inclusion criteria: * men or women ≥ 18 and ≤ 80 years old * subjects must be diagnosed with rheumatoid arthritis for at least 6 months before baseline * active ra defined as ≥ 6 swollen joints and ≥ 6 tender joints at screening and baseline and at least one of the following at screening: * erythrocyte sedimentation rate (esr) ≥ 28 mm/hr * serum c-reactive protein (crp) \> 1.0 mg/dl * subjects must be taking methotrexate (mtx) for ≥ 12 consecutive weeks and on a stable dose of mtx 7.5 to 25 mg/week for ≥ 8 weeks prior to receiving the investigational product (ip), and be willing to remain on a stable dose throughout the study * subject has no known history of active tuberculosis exclusion criteria: * class iv ra, felty's syndrome or history of prosthetic or native joint infection * major chronic inflammatory disease or connective tissue disease other than ra, with the exception of secondary sjögren's syndrome * use of commercially available or investigational biologic therapies for ra as follows: * anakinra, etanercept within 1 month prior to first dose of ip * infliximab, abatacept, tocilizumab, golimumab, certolizumab within 3 months prior to first dose of ip * other experimental or commercially available biologic therapies for ra within 3 months or 5 half-lives (whichever is longer) prior to first dose of ip * previous receipt of rituximab or a biosimilar of rituximab other inclusion/exclusion criteria may apply
clinical evaluation of the aptima® assay for chlamydia trachomatis using the panther™ system

Conditions: Chlamydia Trachomatis

Summary: the objective of this multi-center clinical study is to demonstrate that the aptima(r) assay for chlamydia trachomatis (ct; "act assay"), which is cleared for use on the tigris dts (direct transfer) system ("tigris system"), can be tested on the panther system. the intended use of the act assay will be unchanged except for the inclusion of its use with the panther system. act assay performance on the panther system is comparable to performance on the tigris system.

this protocol was withdrawn from clinical trials.gov because samples collected under this protocol were not tested per protocol using the gen-probe aptima(r) ct (chlamydia trachomatis) assay. instead, testing was conducted and results were generated with the gen-probe aptima(r) combo 2 assay (for chlamydia trachomatis and neisseria gonorrhoeae). see protocol identification ac2ps-us11-001 (nct01733069) for results. this action was recommended by the rrs team per their email to me on 8 february 2013.

Eligibility criteria:
inclusion criteria: * the subject is at least 14 years of age at the time of informed consent and is sexually active * the subject reports symptoms consistent with a suspected std such as abnormal discharge, genital itching, pain/discomfort during sexual intercourse or urination, and/or lower abdominal discomfort. * if the subject is asymptomatic, the subject is known to be partners with, or a contact of, a person with a confirmed or suspected std(s), is undergoing screening evaluation for a possible std(s), and/or is scheduled for a routine exam that may include a pelvic exam * the subject and/or legally authorized representative is willing to undergo the informed consent process prior to study participation (a minor will need the documented consent of his/her parent or legal guardian, unless the site has an irbapproved waiver for parental consent for minors) exclusion criteria: * a potential subject will be ineligible for clinical trial enrollment if the subject, clinician, or medical record reports any of the following: * the subject took antibiotic medications within the last 21 days * the subject is underage (as defined by the irb or state law), without the documented consent of her/his parent or legal guardian (exception: sites that have an irbapproved waiver for parental consent for minors) * the subject is determined by the investigator to be medically unsuitable for participation in this study (eg, medical history of concurrent illness that could result in an unacceptable risk to the subject) concurrent participation in other clinical study(ies) may be acceptable, with approval by the investigator and sponsor.

Keywords: chlamydia trachomatis aptima assay for chlamydia trachomatis
the evaluation of therapeutic efficacy on the integrated group psychotherapy for patients with schizophrenia

Conditions: Schizophrenia

Summary: although the patients with schizophrenia can be treated with new generation of antipsychotics medication, additional approaches are necessary to improve schizophrenics' cognitive functions, interpersonal relationships as well as social adjustment. when some of patients return to community, they expose to practical pressure that contribute to worsen and relapse of disease. that further damages patient's cognitive functions. integrated psychological therapy(ipt) on treating schizophrenia has dramatic improvement in recent years; it has formed structured treatment gradually on relieving illusion, hallucination as well as negative symptoms. this study aims at conducting 12-week structured ipt group therapy. the intended subjects are patients, met with dsm-ⅳ-tr diagnosis of schizophrenia, from community, outpatient and inpatient service. the overall treatments are designed to provide 1-2 hours weekly group therapy which focuses on relieving illusions, hallucination, and negative symptoms. patients' cognitive functions, ability of emotional adjustment and interpersonal relationship would be evaluated in pre-test and post-test to indicate whether the significant difference exists. there is a controlled group, in which patients who still receive treatment as usual (tau). the study also compares the evaluation results between ipt group and tau group, hoping to develop the therapeutic framework for taiwan people with schizophrenia.


Eligibility criteria:
inclusion criteria: * schizophrenia, * can concentrate in group for 30 minutes. exclusion criteria: * substance abuse (alcohol, illegal medication), * self harm history.
mind-body therapy (remotely delivered) for knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: this proposal aims to provide crucial knowledge about the neurobiological mechanisms underlying tai chi mind-body therapy for knee osteoarthritis (oa). the central mechanism of knee oa pain will be investigated using brain imaging technology to evaluate how brain function and structure change in response to mind-body exercise over time. sixty eligible individuals who meet the american college of rheumatology criteria for knee oa will be randomized into tai chi or wellness education interventions for 12 weeks. the investigators will compare changes in resting state functional connectivity of the cognitive control network, and functional magnetic resonance imaging responses to pressure pain and brain morphometry, as well as their association with clinical outcomes. the findings will lead to the establishment of a new treatment paradigm in oa and have broad application to the management of chronic musculoskeletal pain.

the study will investigate the central mechanism of knee oa pain using brain imaging technology to evaluate how brain function and structure change in response to mind-body exercise over time. tai chi mind body therapy may work by modulating the interaction among cognitive control network, default mode network, descending pain modulation system, limbic system, salient network, and sensory motor system through complex mind-body interactions. by combining multiple brain imaging modalities measurements, investigators will examine the neural substrates of tai chi compared with wellness education in adults with knee oa. the investigators will compare changes in resting state functional connectivity of the cognitive control network, brain morphometry and functional magnetic resonance imaging responses to pressure pain, as well as their association with clinical outcomes. results of this innovative mechanistic study will have important therapeutic implications and provide critical insight into the clinical, behavioral, and neurobiological mechanisms of the potential disease-modifying role of mind-body therapies for knee oa.

Eligibility criteria:
inclusion criteria: * age 50 years or older * unilateral or bilateral knee oa * fulfills the american college of rheumatology criteria for symptomatic knee oa * willing to undergo mri at baseline and follow-up * womac pain subscale score ≥2 on weight-bearing questions exclusion criteria: * serious medical conditions limiting ability of patient to participate in the study such as, symptomatic cardiovascular, symptomatic pulmonary disease requiring supplemental oxygen, uncontrolled metabolic diseases, severe renal and liver disease * presence of any contraindications to fmri scanning. including but not limited to: cardiac pacemaker, metal implants, fear of closed spaces, pregnancy, weight \>300 lbs
naloxone treatment in skåne county - effect on drug-related mortality and overdose-related complications

Conditions: Opioid Abuse

Summary: death in overdose is the single most common cause of death in people using heroin. in sweden, the number of drug-related overdose deaths has increased gradually since the early 1990s. the purpose of the study is to investigate the effects of a naloxone distribution program in skåne county. the primary issue is whether the project had an effect on overdose mortality and overdose related injuries.


Eligibility criteria:
inclusion criteria: * subjects treated at the addiction centres of skåne county * signed informed consent exclusion criteria: * subjects unable to understand study information due to psychiatric co-morbidity or severe language difficulties

Keywords: opioid overdose mortality naloxone substance use disorder prevention
exercise and pelvic floor health education program effectiveness

Conditions: Urinary Incontinence; Pelvic Floor Disorders; Exercise Addiction

Summary: the aim of the study is investigation of the effectiveness of pelvic floor health education and exercise program in women with urinary incontinence. women diagnosed with both stress and mixed type urinary incontinence were included the study. pelvic floor health education and exercise program were applied to women for 12 weeks.

3 group were created; the first group will applied pelvic floor health education composed presentation about women health,urinary incontinence, teaching anatomy of the pelvic floor and bladder training ,second group will applied both pelvic floor health education and exercise of pelvic floor muscles for 12 weeks and third group will be control group.women with urinary incontinence were included the study are continued 12 weeks . first evaluation is done before education and exercise program, and second evaluation in 6.week and last evaluation after 12 weeks exercise and education program.

Eligibility criteria:
inclusion criteria: 1. the ages between 18-65 with urinary incontinence 2. volunteer women who can regularly apply the pelvic floor muscle exercise program exclusion criteria: 1. having pelvic organ prolapse (stage≥2), 2. women who are in the neonatal and postnatal period (up to 3 months after birth), 3. situations that will prevent evaluation or communication (cognitive problems, etc.). 4. having a neurological disorder,having urinary tract infection, 5. those who received urinary incontinence treatment or had an operation, • women who have received training on the pelvic floor before

Keywords: urinary incontinence exercise pelvic floor health education
effects of phototherapy on gait and balance of post-stroke individuals

Conditions: Post-stroke in Association to Phototherapy

Summary: hemiparesis and/or hemiplegia is one of the most common clinical signs of stroke, characterized by partial or complete loss of motor function, resulting in varying degrees of impairment and disability. the aim of this study is evaluate the acute effects of application of phototherapy to detect if this therapeutic approach may be beneficial in gait and balance post-stroke individuals. for such, 10 volunteers, with a history of injury (stroke) between 6 months to 5 years, with deficit in functional capacity in the gait due spasticity of extensor muscles of the affected limb, specifically the triceps sural. the evaluation will consist of three-dimensional gait analysis, muscle activity during gait, mobility, static and functional balance, and mobility of volunteers.

this is a clinical, randomized, placebo-controlled, crossover and triple-blind study. ten participants with injury history (stroke) will perform the protocol. the intervention will be held once a week for 4 weeks. each week a different dose of phototherapy (placebo, 10j, 30j and 50j) will be applied. the phototherapy, active or placebo, will be applied in 9 different points of anterior muscle of the thigh, 6 different points of posterior muscle of the thigh and 2 different points of the gastrocnemius muscle, bilaterally, before the tests. only one investigator, that will not participat in any phase of the assessments sessions, will know about what program is active or placebo in phototherapy device. randomisation will occur by a simple drawing of lots (a, b, c, or d) in the first visit. the phototherapy unit emitted the same sound regardless of the program used, active or placebo. for three-dimensional gait assessment and muscle activity will be used a smart-d system 140® - bts engineering with six cameras, two kistler force platforms platform model 9286ba and freeemg® electromyography - bts engineering wireless system with four channels. in addition, the evaluation will quantify the static balance (force platform), the functional balance (berg balance scale) and mobility (6 minute walk test and go upand team test).

Eligibility criteria:
inclusion criteria: * hemiparetic adults with a single stroke event, with crural predominance; * injury (stroke) from 6 months to 5 years; * aged between 40 and 60 years old; * in treatment at the uninove physical therapy clinic; * able to walk barefoot, with or without support; * with verbal comprehension, controlled systemic disease and clinically stable; * able to perform the 6-minute walk test. exclusion criteria: * subjects with fixed deformities, previous surgery, previous osteoarticular dysfunction, any disease that influences the performance of the march; * cognitive impairment detrimental to the tests; * subjects who do not fit the inclusion criteria.

Keywords: stroke phototherapy gait balance functional mobility